In a recent announcement, the FDA granted 510(k) clearance to AIRAmed for AIRAscore—a cutting-edge medical image management and processing tool that integrates deep learning and artificial intelligence (AI). This advanced tool is specifically designed to detect Alzheimer’s disease (AD) and related dementias at their earliest stages. While AIRAscore has been available in Europe for four years, it will soon be accessible in the US by the first quarter of 2024.
With AIRAscore, clinicians can efficiently evaluate MRI brain scans and compare them to a sizable reference database, factoring in head size, age, and gender. The technology provides precise measurements of tissue volumes, including details on various brain regions and limbic structures. This capability allows clinicians to pinpoint abnormal brain volumes, aiding in the differentiation of different forms of dementia and movement disorders.
Tobias Lindig, MD, founder and managing director of AIRAmed, as well as a specialist in radiology and neurology at the University Hospital Tubingen, explained, “For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias. However, we know from several studies that patients with these brain diseases suffer from subtle brain volume loss early in their disease course that cannot be observed with the human eye. With AIRAscore, we are now offering physicians a highly precise, quantitative tool for the rapid detection of areas with a brain volume below the normal range.”
AIRAscore is not only highly accurate but also cost-effective. It can be configured by a hospital’s or radiology facility’s IT department in under an hour. Moreover, it offers automated segmentation of crucial brain components, including grey matter, white matter, cerebrospinal fluid, and T1 hyperintensities, while providing detailed measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems to support the diagnostic process.
Lindig added, “We believe our technology has the potential to be a game changer in thepatient care journey, as brain volumes are of interest to physicians in the early disease course and also during the course of a disease to monitor the brain volume over time during therapy.”
This technology offers several advantages, providing a standardized and objective view of the brain. By comparing patients to a reference group of similar age and gender, clinicians can detect atrophy at an earlier stage than traditional visual examinations can. Furthermore, deviations from the normal aging process can be identified during follow-up examinations, even before atrophy surpasses age-appropriate levels.
Ahmed Othman, a neuroradiologist at the University Hospital Mainz, Germany, remarked, “The innovative brain volumetry system AIRAscore offers new possibilities in diagnosis and treatment of neurodegenerative diseases with an easily accessible surrogate parameter of disease activity. This is a big milestone for early detection, differential diagnostics, and disease monitoring in dementias.”
The FDA’s decision to clear AIRAscore comes at a pivotal moment, as novel therapeutics for neurodegenerative diseases are entering the treatment landscape.These therapies, including lecanemab (Leqembi; Eisai), are available for individuals with confirmed diagnoses of mild cognitive impairment or mild AD supported by documentation of amyloid-ß in the brain.